Biologics and Substitution: Advocating for Your Right to Know

Would you want your pharmacist to tell you and your doctor if they substituted your biologic medication with a similar, but not identical drug?

Of course you would. But as biosimilars a less expensive mimic of Biologics are introduced on the U.S. market, individual states are deciding how and when they can be substituted. This includes whether you and your doctor will be notified of the substitution. Pharmacist associations are lobbying against notification, claiming that it will take away time they need for patient care. Representing you in this battle is the Global Healthy Living Foundation (GHLF), the parent organization of CreakyJoints.

"We must remain vigilant about the transparency of the process and the barriers," says Stephen Marmaras, Manager of State and National Advocacy with GHLF.
He is coordinating a grassroots network of GHLF Super Advocates to "ensure that the patient perspective is infused in conversations at the local and federal level."

What are biosimilars and why should you care?

"Biologics are one of the most complex medications," Stephen explains. "They are created of living organisms and living cells and many scientists believe it's not possible to create a generic version." Instead, manufacturers are creating biosimilars, which mimic Biologics, some of which are classified as interchangeable (for more details, see my post on biosimilars).

Biosimilars are very promising for a number of reasons. Because they're slightly different than the Biologics they mimic, biosimilars represent additional treatment options. As well, they will be cheaper by about 30-40 percent, addressing the barrier to care represented by the high price of Biologics.

However, biosimilars are a "double-edged sword," Stephen says. Although interchangeable biosimilars will have the same clinical results as the biologic they mimic, the differences between the two drugs could add some risk in terms of side effects and safety. "There are concerns about safety and transparency in the [approval] process " The essential decisions are how they're named, how they are labelled, and how the data is extrapolated," he explained.

An additional concern is related to substitution. Insurance companies establish a formulary for complex diseases with complicated treatments. This involves a number of tiers, for instance the preferred tier, tier 2 and tier 3. After a bidding process, the drug that has the best "clinical value and cost, the drug that is most effective at the most competitive price," will be on the preferred tier.

"Insurance companies have an incredible amount of control over what drug you get. For instance, your doctor can prescribe Humira but your insurance says you have to fail Enbrel first, even if you have failed it in the past," Stephen told me. In this example, Enbrel would be on the preferred tier. He went on to predict that "when biosimilars hit the US market, they will become the preferred option for insurance." When they are, pharmacists will substitute biosimilars for a prescribed biologic. This is when notification is important.

Your voice matters

"It is not appropriate to apply policy from generic drug substitution to biosimilars," Stephen said. Substituting generic small molecule oral drugs is common generic versions are chemically identical to the brand name. However, biosimilars are not identical to Biologics.

"There is a misconception about what biosimilars are," says Regan Reynolds. "They're not generic. They serve same function, but are a different animal." Regan has ankylosing spondylitis and participated in advocacy at her state legislature in North Carolina. "If my biologic has two biosimilars and my mail-order pharmacy substitutes, I need to know which one I'm on." She explained that should she have a reaction, it could range from an injection site reaction to an anaphylactic one. Having the correct information about her medication is an essential part of being able to interact with medical staff in a potential emergency.

Regan volunteers for the GHLF advocacy initiative to ensure that state laws include pharmacist communication. GHLF is part of a coalition of stakeholders representing patient voices. They are traveling all over the U.S., advocating for communication to patients and physicians being part of laws governing the administration of biosimilars.

"It's important that patients share their opinion," Stephen said. "Policies are directly connected to the quality of care and quality of product and intended product the patient receives." He encouraged people in the inflammatory arthritis community to get involved with advocacy, mentioning that the patient opinion can create positive change on the legislative level.

"The consumer should be the perspective most taken into account," he said. "It's important to get involved in whatever way you feel comfortable." Stephen recommended connecting with advocacy organizations, such as the GHLF and the 50 State Network. They can help provide information and an opportunity for you to share your opinion through speaking to legislators, writing letters to the editor, and many other opportunities.

"The message should be that the biosimilars have the opportunity to represent incredible hope, but also risk to patients. We need to be vigilant," Stephen said. Regan said that she believes everyone who is on a biologic must feel strongly about advocating. "It helps both you personally and the community."